SBIR Phase I: Filter Removal of Glass - A better way of filtering injectables

SBIR 第一阶段：过滤器去除玻璃 - 过滤注射剂的更好方法

• 批准号: 2232923
• 负责人: Sue Carr
• 金额: $ 27.5万
• 依托单位: CARRTECH LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2232923&HistoricalAwards=false
• 关键词: SBIR; Phase; Filter; Removal; Glass

The broader impact/commercial potential of this Small Business innovation Research (SBIR) Phase I project is an integrated, single needle filter which removes glass shards from injectable fluids. Liquid pharmaceuticals and medications are often stored in glass ampoules. To gain access to these medications, each ampoule is manually broken at the neck by a health care provider. This can result in glass shards entering the medication that can cause patient hematomas and/or internal bleeding. United States regulations currently mandate all ampoules must be filtered by health care providers prior to injection which requires a multi-step filter process using multiple needles and needle exchanges. This project aims to develop a single, effective, inline filter which that requires half the time of this current process, while improving safety for the patient and the healthcare worker by reducing the risks of needle stick injuries. The commercial potential is to become the standard of care for the $3 billion global filter market and consumes over six billion disposable glass ampoules every year.This Small Business Innovation research (SBIR) Phase I project is a novel, disposable, inline, mechanical filter with optimal porosity and density to remove glass ampoule shards. The current practice of breaking ampules at their neck to access medication results in shards that are currently manually filtered using a filter needle prior to administration into the patient. The filter needle must be removed and discarded, and a second sterile needle placed on the syringe for injection. The company aims to develop a novel, all-in-one, integrated filter and needle system utilizing a single inner blunt needle with a novel filter located at the distal end versus the current proximal end where the Luer loc is located. This solution will enable a single step process for glass filtering and medication injection. The scope of activities includes engineering and validation tests of leakage, pull force, dead volume, labeling and packaging, handling safety, repeatability/consistency, and accelerated aging of the company’s proprietary design concepts. This project aims to provide an assembly suitable for human use that is manufacturable at scale in a cost-effective manner.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

该小型企业创新研究 (SBIR) 第一阶段项目的更广泛影响/商业潜力是一个集成的单针过滤器，可去除注射液中的玻璃碎片，液体药品和药物通常储存在玻璃安瓿中，以便获取这些药物。 ，每个安瓿均由医疗保健人员在颈部手动打碎，这可能会导致玻璃碎片进入药物，从而导致患者血肿和/或内出血。美国法规目前强制要求所有安瓿必须使用。在注射前由医疗保健提供者进行过滤，这需要使用多个针头和针头交换的多步骤过滤过程。该项目旨在开发一种单一、有效的在线过滤器，该过滤器所需的时间是当前过程的一半，同时提高了安全性。通过降低针刺伤害的风险，为患者和医护人员提供服务。其商业潜力将成为价值 30 亿美元的全球过滤器市场的护理标准，每年消耗超过 60 亿个一次性玻璃安瓿。这项小型企业创新研究（ SBIR）第一阶段项目是具有最佳孔隙率和密度的新型一次性内联机械过滤器，可去除玻璃安瓿碎片。目前，在将安瓿注射到患者体内之前，需要通过在安瓿颈部打碎玻璃碎片来获取药物，从而产生碎片。必须拆除并丢弃过滤针，并将第二根无菌针放置在注射器上进行注射。该公司的目标是开发一种新型、一体式、集成的过滤器和针头系统，利用单个内部钝针头。位于远端的新型过滤器与鲁尔定位器所在的当前近端相比，该解决方案将实现玻璃过滤和药物注射的单步过程。活动范围包括泄漏、拉力、该项目旨在提供一种适合人类使用的组件，该组件可以以具有成本效益的方式大规模制造。通过使用基金会的智力价值和更广泛的影响审查标准进行评估，NSF 的法定使命被认为值得支持。